Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
26 participants
INTERVENTIONAL
2012-05-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Pretreatment with metformin
Pretreatment with metformin 500 mg three times a day for 3 days.
Metformin
metformin 500 mg three times a day, for 3 days
No pretreatment.
no intervention
No interventions assigned to this group
Pretreatment with Metformin/caffeine
to study whether caffeine (4 mg/kg intravenously over 10 minutes) attenuates the protective effect of metformin (500 mg three times a day for 3 days) on FMD after ischemia/reperfusion
Pretreatment with metformin in combination of infusion of caffeine.
Pretreatment with metformin 500 mg three times a day for 3 days, in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes) prior to FMD measurement
No metformin, only pretreatment with caffeine
No pretreatment with metformin, FMD measurement after forearm ischemia/reperfusion and infusion of caffeine (4 mg/kg intravenously over 10 minutes).
No pretreatment with metformin in combination with infusion of caffeine
No pretreatment with metformin in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes).
Interventions
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Metformin
metformin 500 mg three times a day, for 3 days
Pretreatment with metformin in combination of infusion of caffeine.
Pretreatment with metformin 500 mg three times a day for 3 days, in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes) prior to FMD measurement
No pretreatment with metformin in combination with infusion of caffeine
No pretreatment with metformin in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes).
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Hypertension (in supine position: systolic BP \> 140 mmHg, diastolic BP \> 90 mmHg)
* Hyperlipidaemia (fasting total cholesterol \> 5.5 mmol/L or random \> 6.5 mmol/L)
* Diabetes Mellitus (fasting glucose \> 7.0 mmol/L or random glucose \> 11.0 mmol/L)
* History of any cardiovascular disease
* Concomitant use of medication
* Renal dysfunction (MDRD \< 60 ml/min)
* Professional athletes
30 Years
50 Years
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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N. Riksen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
G.A. Rongen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
D.H. Thijssen, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Countries
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References
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El Messaoudi S, Schreuder TH, Kengen RD, Rongen GA, van den Broek PH, Thijssen DH, Riksen NP. Impact of metformin on endothelial ischemia-reperfusion injury in humans in vivo: a prospective randomized open, blinded-endpoint study. PLoS One. 2014 Apr 22;9(4):e96062. doi: 10.1371/journal.pone.0096062. eCollection 2014.
Other Identifiers
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Metformin-FMD 001
Identifier Type: -
Identifier Source: org_study_id
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